Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Triple-negative breast cancer | Hormone receptor-low positive HER2-negative breast cancer

Phase III trial of SACITUZUMAB TIRUMOTECAN for Triple-negative breast cancer | Hormone receptor-low positive HER2-negative breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple-negative breast cancer | Hormone receptor-low positive HER2-negative breast cancer
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
01-05-2025
First CTIS Authorization Date
27-08-2025

Trial design

Randomised, open-label, chemotherapy (comparator arm: standard chemotherapy regimens including anthracycline- and taxane-based agents such as epirubicin, doxorubicin, cyclophosphamide, paclitaxel, carboplatin) in combination with pembrolizumab; specific dose/schedule not specified in the summary (see protocol for regimen details).-controlled Phase III trial in Finland, Portugal, Sweden and others.

Randomised
Yes
Open Label
Yes
Comparator
Chemotherapy (comparator arm: standard chemotherapy regimens including anthracycline- and taxane-based agents such as epirubicin, doxorubicin, cyclophosphamide, paclitaxel, carboplatin) in combination with pembrolizumab; specific dose/schedule not specified in the summary (see protocol for regimen details).
Target Sample Size
2047

Eligibility

Recruits 2047 Vulnerable population not selected (isVulnerablePopulationSelected=false). Standard informed consent by the adult participant is used; no assent procedures for minors are described in the record..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false). Standard informed consent by the adult participant is used; no assent procedures for minors are described in the record.

Inclusion criteria

  • {"criterion_text":"- Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2\n- Has centrally confirmed diagnosis of BC that is triple-negative or hormone receptor (HR)-low positive/ human epidermal growth factor receptor-2 (HER2) negative, based on the American Society of Clinical Oncology/College of American Pathologists guidelines\n- Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization\n- Has left ventricle ejection fraction of ≥50% or ≥ institution lower limit of normal as assessed by echocardiogram or multigated acquisition scan performed at screening\n- Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2, Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin."}

Exclusion criteria

  • {"criterion_text":"- Has Grade ≥2 peripheral neuropathy\n- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing\n- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n- Has uncontrolled systemic disease (eg, uncontrolled hypertension or diabetes, or clinically symptomatic pleural effusion, pericardial effusion, or ascites)\n- Has human immunodeficiency virus and a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed BC\n- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n- Known additional malignancy that is progressing or has required active treatment within the past 5 years\n- Active autoimmune disease that has required systemic treatment in the past 2 years\n- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n- Concurrent active Hepatitis B or Hepatitis C virus infection\n- History of stem cell/solid organ transplant\n- Has not adequately recovered from major surgery or has ongoing surgical complications"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0\n- Event-Free Survival (EFS)","definition_or_measurement_approach":"pCR: using the definition of ypT0/Tis ypN0 as assessed by local pathologist at the time of surgery. EFS: assessed by investigator."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS)\n- pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0\n- pCR (ypT0/Tis ypN0) in Participants with High-Risk, Early-Stage, Triple Negative Breast Cancer (TNBC)\n- EFS in Participants with High-Risk, Early-Stage, TNBC\n- OS in Participants with High-Risk, Early-Stage, TNBC\n- Distant Progression or Distant Recurrence-Free Survival (DPDRFS)\n- Change from Baseline in the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score\n- Change from Baseline in EORTC-QLQ-C30 Physical Functioning Score\n- Change from Baseline in EORTC QLQ-C30 Role Functioning Score\n- Change from Baseline in EORTC QLQ-C30 Fatigue Score\n- Change from Baseline in EORTC QLQ-Breast Cancer Questionnaire (BR42) Systemic Therapy Side Effects\n- Number of Participants with One or More Adverse Events (AEs)\n- Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"OS: overall survival. pCR-No DCIS: using ypT0 ypN0 definition. pCR (subgroup): using ypT0/Tis ypN0 assessed by local pathologist. EFS/DPDRFS: time-to-event measures assessed by investigator. HRQoL: change from baseline using EORTC QLQ-C30 and QLQ-BR42 questionnaires. AEs and discontinuations: counted as number of participants with events or who discontinue due to AE."}

Recruitment

Registry Or Advocacy Recruitment
True, advocacy materials (Advocacy Card) are referenced in recruitment documents; no specific external registry or advocacy organisation names are provided in the record.
Planned Sample Size
2047
Recruitment Window Months
113
Consent Approach
Informed consent obtained from the participant (adult participants). Country-specific main consent forms (L1_ICF_Main consent) and optional consent modules (optional imaging, tissue sample, genetic consent, pregnancy follow-up, optional withdrawal, Greenphire, ClinCard etc.) are provided. Consent documents are available in multiple country/language versions (examples in the record: English, Portuguese, French, Spanish, Polish, Swedish, Czech, German, Greek, Hungarian, Italian, Romanian, Norwegian, Dutch, Finnish).

Methods

  • Patient brochures (country-specific patient brochure documents listed in recruitment materials)
  • Patient visit guides (country-specific patient visit guides listed)
  • Print advertisements (e.g., DE print ad listed)
  • Advocacy materials / advocacy card (advocacy card documents listed)
  • Recruitment arrangements documents and local ICF procedures (K1 documents per country)

Geography

Total Number Of Sites
92
Total Number Of Participants
598

Finland

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
105
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Oulu University Hospital
Department Name
Cancer Center
Principal Investigator Name
Sanna Iivanainen
Principal Investigator Email
sanna.iivanainen@pohde.fi
Contact Person Name
Sanna Iivanainen
Contact Person Email
sanna.iivanainen@pohde.fi
Site Name
Tampere University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Niina Maenpaa
Principal Investigator Email
niina.maenpaa@pirha.fi
Contact Person Name
Niina Maenpaa
Contact Person Email
niina.maenpaa@pirha.fi
Site Name
HUS-Yhtymae
Department Name
Comprehensive Cancer Center
Principal Investigator Name
Peeter Karihtala
Principal Investigator Email
peeter.karihtala@hus.fi
Contact Person Name
Peeter Karihtala
Contact Person Email
peeter.karihtala@hus.fi

Portugal

Earliest CTIS Part Ii Submission Date
02-07-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
128
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Galo Saude Parcerias Cascais S.A.
Department Name
Serviço de Oncologia
Principal Investigator Name
Diogo Costa
Principal Investigator Email
diogo.santos.costa@hospitaldecascais.pt
Contact Person Name
Diogo Costa
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Susana Amaral
Principal Investigator Email
susana.amaral@ipopporto.min-saude.pt
Contact Person Name
Susana Amaral
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Oncologia
Principal Investigator Name
Isabel Augusto
Principal Investigator Email
isabel.augusto@ulssjoao.min-saude.pt
Contact Person Name
Isabel Augusto
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Susana Almeida
Principal Investigator Email
sfalmeida@ulslo.min-saude.pt
Contact Person Name
Susana Almeida
Contact Person Email
sfalmeida@ulslo.min-saude.pt

Sweden

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
49
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
Department Name
Onkologmottagning, Södra Älvsborgs Sjukhus
Principal Investigator Name
Zakaria Einbeigi
Principal Investigator Email
zakaria.einbeigi@vgregion.se
Contact Person Name
Zakaria Einbeigi
Contact Person Email
zakaria.einbeigi@vgregion.se
Site Name
Uppsala University Hospital
Department Name
Onkologikliniken, Akademiska Sjukhusest, Uppsala
Principal Investigator Name
Aglaia Schiza
Principal Investigator Email
aglaia.maleka@akademiska.se
Contact Person Name
Aglaia Schiza
Contact Person Email
aglaia.maleka@akademiska.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO hematologi, onkologi och strålningsfysik
Principal Investigator Name
Ulrik Narbe
Principal Investigator Email
Ulrik.Narbe@skane.se
Contact Person Name
Ulrik Narbe
Contact Person Email
Ulrik.Narbe@skane.se
Site Name
Karolinska University Hospital
Department Name
Tema Cancer, ME Bröst-, endokrina tumörer och sarkom
Principal Investigator Name
Theodoros Foukakis
Principal Investigator Email
theodoros.foukakis@ki.se
Contact Person Name
Theodoros Foukakis
Contact Person Email
theodoros.foukakis@ki.se

Czechia

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
6
Number Of Sites
4
Number Of Participants
21

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Principal Investigator Name
Katarína Petráková
Principal Investigator Email
petrakova@mou.cz
Contact Person Name
Katarína Petráková
Contact Person Email
petrakova@mou.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddělení radioterapie a onkologie
Principal Investigator Name
Magdalena Halámka
Principal Investigator Email
magdalena.halamka@nnj.agel.cz
Contact Person Name
Magdalena Halámka
Contact Person Email
magdalena.halamka@nnj.agel.cz
Site Name
Krajska nemocnice Liberec a.s.
Department Name
Komplexní onkologické centrum
Principal Investigator Name
Marek Sochor
Principal Investigator Email
marek.sochor@nemlib.cz
Contact Person Name
Marek Sochor
Contact Person Email
marek.sochor@nemlib.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Principal Investigator Name
Iveta Kolářová
Principal Investigator Email
iveta.kolarova@fnhk.cz
Contact Person Name
Iveta Kolářová
Contact Person Email
iveta.kolarova@fnhk.cz

Germany

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
25
Number Of Sites
9
Number Of Participants
57

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Gynacology (Frauenklinik)
Principal Investigator Name
Peter Fasching
Principal Investigator Email
fk-studienzentrale@uk-erlangen.de
Contact Person Name
Peter Fasching
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Gynacology (Klinik für Gynäkologie und Geburtshilfe)
Principal Investigator Name
Michael Untch
Principal Investigator Email
michael.untch@helios-gesundheit.de
Contact Person Name
Michael Untch
Site Name
St. Vincenz-Krankenhaus GmbH
Department Name
Gynacology (Frauen- und Kinderklinik)
Principal Investigator Name
Michael Patrick Lux
Principal Investigator Email
s.heimann@vincenz.de
Contact Person Name
Michael Patrick Lux
Contact Person Email
s.heimann@vincenz.de
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Breast Clinic (Klinik fuer Frauenheilkunde/Brustzentrum)
Principal Investigator Name
Christian Schem
Principal Investigator Email
studien@mammazentrum.eu
Contact Person Name
Christian Schem
Contact Person Email
studien@mammazentrum.eu
Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
Oncology (Brustklinik)
Principal Investigator Name
Rudolf Weide
Principal Investigator Email
info@invo-koblenz.de
Contact Person Name
Rudolf Weide
Contact Person Email
info@invo-koblenz.de
Site Name
Luisenkrankenhaus GmbH & Co. KG
Department Name
Gynacological Oncology (Gynäkologische Onkologie)
Principal Investigator Name
Athina Kostara
Principal Investigator Email
info@gynonco.de
Contact Person Name
Athina Kostara
Contact Person Email
info@gynonco.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Gynacology (Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Brustzentrum/Studienzentra
Principal Investigator Name
Nadia Harbeck
Principal Investigator Email
nadia.harbeck@med.uni-muenchen.de
Contact Person Name
Nadia Harbeck
Site Name
Universitaet Muenster
Department Name
Gynacology (Sektion Senologie/Brustzentrum Klinik für Frauenheilkunde und Geburtshilfe)
Principal Investigator Name
Joke Tio
Principal Investigator Email
Stefanie.Nienkemper@ukmuenster.de
Contact Person Name
Joke Tio / Stefanie Nienkemper
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Gynacology (Klinik fuer Frauenheilkunde/Brustzentrum)
Principal Investigator Name
Mustafa Deryal
Contact Person Name
Mustafa Deryal

Greece

Earliest CTIS Part Ii Submission Date
30-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
20
Number Of Sites
5
Number Of Participants
26

Sites

Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Vasileios Ramfidis
Principal Investigator Email
ramfidis@gmail.com
Contact Person Name
Vasileios Ramfidis
Contact Person Email
ramfidis@gmail.com
Site Name
Athens Medical Center S.A. (Thessaloniki)
Department Name
Oncology Department
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
A' Department of Internal Medicine
Principal Investigator Name
Helen Gogas
Principal Investigator Email
helgogas@gmail.com
Contact Person Name
Helen Gogas
Contact Person Email
helgogas@gmail.com
Site Name
Areteio Hospital
Department Name
2nd Surgical Department, Oncology Unit
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
Metropolitan Hospital
Department Name
D’ Oncology Department
Principal Investigator Name
Helena Linardou
Principal Investigator Email
elinardou@icloud.com
Contact Person Name
Helena Linardou
Contact Person Email
elinardou@icloud.com

Hungary

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
34
Number Of Sites
5
Number Of Participants
26

Sites

Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Onkológiai Osztály
Principal Investigator Name
Károly Máhr
Principal Investigator Email
mahrkaroly@hotmail.com
Contact Person Name
Károly Máhr
Contact Person Email
mahrkaroly@hotmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
B-Belgyógyászati Onkológiai Osztály
Principal Investigator Name
Gábor Rubovszky
Principal Investigator Email
rubovszky.gabor@oncol.hu
Contact Person Name
Gábor Rubovszky
Contact Person Email
rubovszky.gabor@oncol.hu
Site Name
University Of Szeged
Department Name
Onkoterápiás Klinika
Principal Investigator Name
Alíz Nikolényi
Principal Investigator Email
nikolenyi.aliz@gmail.com
Contact Person Name
Alíz Nikolényi
Contact Person Email
nikolenyi.aliz@gmail.com
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Klinikai Onkológiai és Sugárterápiás Centrum
Principal Investigator Name
Gergely Dombovári
Principal Investigator Email
dombovaridr@freemail.hu
Contact Person Name
Gergely Dombovári
Contact Person Email
dombovaridr@freemail.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Principal Investigator Name
Zsolt Horváth
Principal Investigator Email
horvathzso.study@kmk.hu
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu

Italy

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
40
Number Of Sites
13
Number Of Participants
72

Sites

Site Name
Istituto Oncologico Veneto
Department Name
Oncologia Medica 2
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@iov.veneto.it
Contact Person Name
Valentina Guarneri
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Giampaolo Bianchini
Principal Investigator Email
bianchini.giampaolo@hsr.it
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Oncologia Medica 1
Principal Investigator Name
Carmelo Bengala
Principal Investigator Email
carmelo.bengala@ao-pisa.toscana.it
Contact Person Name
Carmelo Bengala
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UOC Clinica di Oncologia Medica
Principal Investigator Name
Lucia Del Mastro
Principal Investigator Email
lucia.delmastro@hsanmartino.it
Contact Person Name
Lucia Del Mastro
Contact Person Email
lucia.delmastro@hsanmartino.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Ginecologia Oncologica - UOS Senologia Medica
Principal Investigator Name
Ida Paris
Principal Investigator Email
ida.paris@policlinicogemelli.it
Contact Person Name
Ida Paris
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
UOC Oncologia Medica
Principal Investigator Name
Pierosandro Tagliaferri
Principal Investigator Email
tagliaferri@unicz.it
Contact Person Name
Pierosandro Tagliaferri
Contact Person Email
tagliaferri@unicz.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Oncologia Medica 1
Principal Investigator Name
Fabio Calabrò
Principal Investigator Email
fabio.calabro@ifo.it
Contact Person Name
Fabio Calabrò
Contact Person Email
fabio.calabro@ifo.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UOC Clinica di Oncologia Medica
Principal Investigator Name
Marina Elena Cazzaniga
Principal Investigator Email
marinaelena.cazzaniga@irccs-sangerardo.it
Contact Person Name
Marina Elena Cazzaniga
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SC Oncologia Medica 1
Principal Investigator Name
Claudio Vernieri
Principal Investigator Email
claudio.vernieri@istitutotumori.mi.it
Contact Person Name
Claudio Vernieri
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica
Principal Investigator Name
Giacomo Allegrini
Principal Investigator Email
giacomo.allegrini@uslnordovest.toscana.it
Contact Person Name
Giacomo Allegrini
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
SC Oncologia
Principal Investigator Name
Alberto Zambelli
Principal Investigator Email
azambelli@asst-pg23.it
Contact Person Name
Alberto Zambelli
Contact Person Email
azambelli@asst-pg23.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Oncologia Medica Provinciale
Principal Investigator Name
Filippo Giovanardi
Principal Investigator Email
filippo.giovanardi@ausl.re.it
Contact Person Name
Filippo Giovanardi
Contact Person Email
filippo.giovanardi@ausl.re.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica Oncologica
Principal Investigator Name
Rossana Berardi
Principal Investigator Email
rossana.berardi@ospedaliriuniti.marche.it
Contact Person Name
Rossana Berardi

Romania

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
19
Number Of Sites
6
Number Of Participants
33

Sites

Site Name
Oncomed S.R.L.
Department Name
ONCOLOGY
Principal Investigator Name
CRISTINA-MARINELA OPREAN
Principal Investigator Email
office@oncohelp.ro
Contact Person Name
CRISTINA-MARINELA OPREAN
Contact Person Email
office@oncohelp.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
ONCOLOGY
Principal Investigator Name
NICOLETA-ZENOVIA ANTONE
Principal Investigator Email
office@iocn.ro
Contact Person Name
NICOLETA-ZENOVIA ANTONE
Contact Person Email
office@iocn.ro
Site Name
Spitalul Clinic Filantropia
Department Name
ONCOLOGY
Principal Investigator Name
MIRCEA-DRAGOS MEDIAN
Principal Investigator Email
office@spitalulfilantropia.ro
Contact Person Name
MIRCEA-DRAGOS MEDIAN
Contact Person Email
office@spitalulfilantropia.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
ONCOLOGY
Principal Investigator Name
MICHAEL SCHENKER
Principal Investigator Email
office@centruldeoncologie.ro
Contact Person Name
MICHAEL SCHENKER
Contact Person Email
office@centruldeoncologie.ro
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncology
Principal Investigator Name
Bogdan Gafton
Principal Investigator Email
secretariat@iroiasi.ro
Contact Person Name
Bogdan Gafton
Contact Person Email
secretariat@iroiasi.ro
Site Name
Institutul Regional De Oncologie Iasi (second address)
Department Name
ONCOLOGY
Principal Investigator Name
BOGDAN GAFTON
Principal Investigator Email
secretariat@iroiasi.ro
Contact Person Name
BOGDAN GAFTON
Contact Person Email
secretariat@iroiasi.ro

Norway

Earliest CTIS Part Ii Submission Date
09-02-2026
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
2
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Akershus University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Stephanie B. Geisler
Principal Investigator Email
stephanie.beate.geisler@ahus.no
Contact Person Name
Stephanie B. Geisler
Site Name
Nordlandssykehuset HF
Department Name
Avdeling for kreft og lindrende behandling
Principal Investigator Name
Bård Mannsåker
Principal Investigator Email
bard.mannsaker@nordlandssykehuset.no
Contact Person Name
Bård Mannsåker
Site Name
Vestre Viken HF
Department Name
Seksjonen for kreftbehandling
Principal Investigator Name
Alina Carmen Porojnicu
Principal Investigator Email
alinacp@vestreviken.no
Contact Person Name
Alina Carmen Porojnicu
Contact Person Email
alinacp@vestreviken.no
Site Name
Helse Stavanger HF
Department Name
Avdeling for blod- og kreftsykdommer (ABK)
Principal Investigator Name
Marius Stensland
Principal Investigator Email
marius.stensland@sus.no
Contact Person Name
Marius Stensland
Contact Person Email
marius.stensland@sus.no

Spain

Earliest CTIS Part Ii Submission Date
17-07-2025
Latest Decision Or Authorization Date
28-08-2025
Processing Time Days
42
Number Of Sites
10
Number Of Participants
80

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology Department
Principal Investigator Name
Rafael Lopez Lopez
Principal Investigator Email
rafael.lopez.lopez@sergas.es
Contact Person Name
Rafael Lopez Lopez
Contact Person Email
rafael.lopez.lopez@sergas.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology Department
Principal Investigator Name
Lucia Gonzalez Cortijo
Principal Investigator Email
lucia.gonzalezc@quironsalud.es
Contact Person Name
Lucia Gonzalez Cortijo
Contact Person Email
lucia.gonzalezc@quironsalud.es
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology Department
Principal Investigator Name
Cesar Augusto Rodriguez Sanchez
Principal Investigator Email
carodriguez@saludcastillayleon.es
Contact Person Name
Cesar Augusto Rodriguez Sanchez
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Oncology Department
Principal Investigator Name
Vega Iranzo Gonzalez-Cruz
Principal Investigator Email
iranzo_veg@gva.es
Contact Person Name
Vega Iranzo Gonzalez-Cruz
Contact Person Email
iranzo_veg@gva.es
Site Name
Hospital Universitario De Jaen
Department Name
Oncology Department
Principal Investigator Name
Pedro Sanchez Rovira
Principal Investigator Email
oncopsr@yahoo.es
Contact Person Name
Pedro Sanchez Rovira
Contact Person Email
oncopsr@yahoo.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology Department
Principal Investigator Name
Luis de la Cruz Merino
Principal Investigator Email
luis.cruz.sspa@juntadeandalucia.es
Contact Person Name
Luis de la Cruz Merino
Site Name
Hospital Del Mar
Department Name
Oncology Department
Principal Investigator Name
Maria Martinez Garcia
Principal Investigator Email
mariamartinezgarcia@psmar.cat
Contact Person Name
Maria Martinez Garcia
Contact Person Email
mariamartinezgarcia@psmar.cat
Site Name
Hospital Universitario Basurto
Department Name
Oncology Department
Principal Investigator Name
Elena Galve Calvo
Principal Investigator Email
elena.galvecalvo@osakidetza.eus
Contact Person Name
Elena Galve Calvo
Site Name
Institut Catala D'oncologia
Department Name
Oncology Department
Principal Investigator Name
Rafael Villanueva Vazquez
Principal Investigator Email
ravillanueva@iconcologia.net
Contact Person Name
Rafael Villanueva Vazquez
Contact Person Email
ravillanueva@iconcologia.net
Site Name
Hospital Beata Maria Ana
Department Name
Oncology Department
Principal Investigator Name
Maria Gion Cortes
Principal Investigator Email
mariagion@gmail.com
Contact Person Name
Maria Gion Cortes
Contact Person Email
mariagion@gmail.com

France

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
38
Number Of Sites
9
Number Of Participants
72

Sites

Site Name
Centre De Cancerologue Du Grand Montpellier
Principal Investigator Name
Cristian Villanueva
Principal Investigator Email
villanueva@ccgm.fr
Contact Person Name
Cristian Villanueva
Contact Person Email
villanueva@ccgm.fr
Site Name
Assistance Publique Hopitaux De Paris
Principal Investigator Name
Elias Assaf
Principal Investigator Email
elias.assaf@aphp.fr
Contact Person Name
Elias Assaf
Contact Person Email
elias.assaf@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncologie Médicale
Principal Investigator Name
Julien Péron
Principal Investigator Email
julien.peron@chu-lyon.fr
Contact Person Name
Julien Péron
Contact Person Email
julien.peron@chu-lyon.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Principal Investigator Name
Thibault De la Motte Rouge
Principal Investigator Email
t.delamotterouge@rennes.unicancer.fr
Contact Person Name
Thibault De la Motte Rouge
Site Name
Institut Curie
Department Name
Unité d'Investigation Clinique
Principal Investigator Name
Delphine Loirat
Principal Investigator Email
delphine.loirat@curie.fr
Contact Person Name
Delphine Loirat
Contact Person Email
delphine.loirat@curie.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Département d'Oncologie Médicale
Principal Investigator Name
Cyriaque Wagner-Ballon
Principal Investigator Email
wagner-ballon.cyriaque@chu-amiens.fr
Contact Person Name
Cyriaque Wagner-Ballon
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie Médicale
Principal Investigator Name
Sylvain Ladoire
Principal Investigator Email
sladoire@cgfl.fr
Contact Person Name
Sylvain Ladoire
Contact Person Email
sladoire@cgfl.fr
Site Name
Institut Paoli Calmettes
Department Name
Service d'Oncologie médicale
Principal Investigator Name
Anthony Goncalves
Principal Investigator Email
goncalvesa@ipc.unicancer.fr
Contact Person Name
Anthony Goncalves
Contact Person Email
goncalvesa@ipc.unicancer.fr
Site Name
Institut Curie (Saint-Cloud)
Department Name
Unité d'Investigation Clinique
Principal Investigator Name
Delphine Loirat
Principal Investigator Email
delphine.loirat@curie.fr
Contact Person Name
Delphine Loirat
Contact Person Email
delphine.loirat@curie.fr

Belgium

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
108
Number Of Sites
5
Number Of Participants
40

Sites

Site Name
Jessa Ziekenhuis
Department Name
Oncology
Principal Investigator Name
Jeroen Mebis
Principal Investigator Email
jeroen.mebis@jessazh.be
Contact Person Name
Jeroen Mebis
Contact Person Email
jeroen.mebis@jessazh.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Oncology
Principal Investigator Name
Andrée Rorive
Principal Investigator Email
andree.rorive@chuliege.be
Contact Person Name
Andrée Rorive
Contact Person Email
andree.rorive@chuliege.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Principal Investigator Name
Donatienne Taylor
Principal Investigator Email
donatienne.taylor@chuuclnamur.uclouvain.be
Contact Person Name
Donatienne Taylor
Site Name
Azorg
Department Name
Oncology
Principal Investigator Name
Greet Huygh
Principal Investigator Email
greet.huygh@olvz-aalst.be
Contact Person Name
Greet Huygh
Contact Person Email
greet.huygh@olvz-aalst.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Principal Investigator Name
Eline Naert
Principal Investigator Email
eline.naert@uzgent.be
Contact Person Name
Eline Naert
Contact Person Email
eline.naert@uzgent.be

Poland

Earliest CTIS Part Ii Submission Date
28-07-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
35
Number Of Sites
11
Number Of Participants
80

Sites

Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddział Onkologiczny - Centrum Kompetencji Raka Piersi, Centrum Kompetencji Raka Jelita Grubego
Principal Investigator Name
Marcin Sokołowski
Principal Investigator Email
onkocwbk@zdrowie.walbrzych.pl
Contact Person Name
Marcin Sokołowski
Contact Person Email
onkocwbk@zdrowie.walbrzych.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
sekretariat.odch@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Krakow)
Department Name
Klinika Onkologii Klinicznej
Principal Investigator Name
Aleksandra Grela-Wojewoda
Principal Investigator Email
aleksandra.grela@krakow.nio.gov.pl
Contact Person Name
Aleksandra Grela-Wojewoda
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Principal Investigator Name
Barbara Radecka
Principal Investigator Email
badaniakliniczne@onkologia.opole.pl
Contact Person Name
Barbara Radecka
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Klinika Onkologii i Immunoonkologii z Oddziałem Dziennym Terapii Onkologicznej
Principal Investigator Name
Monika Kotyla
Principal Investigator Email
clinicaltrialsoffice@poliklinika.net
Contact Person Name
Monika Kotyla
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku
Department Name
Oddział Onkologiczny - Centrum Kompetencji Raka Piersi, Centrum Kompetencji Raka Jelita Grubego
Principal Investigator Name
Wojciech Rogowski
Principal Investigator Email
kopec.em@gmail.com
Contact Person Name
Wojciech Rogowski
Contact Person Email
kopec.em@gmail.com
Site Name
Salve Medica Sp. z o.o. S.K.
Principal Investigator Name
Monika Kukulska
Principal Investigator Email
badaniakliniczne@salvemedica.pl
Contact Person Name
Monika Kukulska
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej im. dr Ewy Pileckiej z pododdziałem Chemioterapii Dziennej
Principal Investigator Name
Kinga Hermanowicz-Szamatowicz
Principal Investigator Email
bco@onkologia.bialystok.pl
Contact Person Name
Kinga Hermanowicz-Szamatowicz
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Principal Investigator Name
Zbigniew Nowecki
Principal Investigator Email
nowotworypiersi@nio.gov.pl
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowotworypiersi@nio.gov.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Żurawski
Principal Investigator Email
badania.kliniczne@co.bydgoszcz.pl
Contact Person Name
Bogdan Żurawski
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Onkologii Klinicznej
Principal Investigator Name
Piotr Mikuliszyn
Principal Investigator Email
badania.kliniczne@onkol.kielce.pl
Contact Person Name
Piotr Mikuliszyn

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Fortrea Inc.
Responsibilities
code:1
Name
IQVIA Limited
Responsibilities
code:4
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Signant Health Global Solutions Limited
Responsibilities
eCOA/eConsent and related services (code:3 / code:7 indicated)

Third parties

  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"Long Term Storage (Tissue)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"DNA extraction","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging sub-study","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long Term Storage (Blood)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited (second entry)","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus:1
Maximum Dose
4 mg/kg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus:2 (marketing authorisation EU/1/15/1024/002)
Maximum Dose
400 mg
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus:2
Maximum Dose
80 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus:2
Maximum Dose
225 mg
Investigational Product Name
DOXORUBICIN
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus:2
Maximum Dose
60 mg/m2
Investigational Product Name
EPIRUBICIN
Active Substance
EPIRUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus:2
Maximum Dose
90 mg/m2
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
prodAuthStatus:2
Maximum Dose
600 mg/m2
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus:2
Maximum Dose
1250 mg/m2 (daily dose UOM mg/m2)
Investigational Product Name
DEXAMETHASONE
Active Substance
DEXAMETHASONE ACETATE, PHENOL, GUAIACOL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus:2
Maximum Dose
2 mg
Combination Treatment
Yes

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